Structure and pharmaceutical formulation development of a new long-acting recombinant human insulin analog studied by NMR and MS
PBN-AR
Instytucja
Narodowy Instytut Leków
Źródłowe zdarzenia ewaluacyjne
Informacje podstawowe
Główny język publikacji
en
Czasopismo
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS [ISSN:0731-7085]
ISSN
0731-7085
EISSN
Wydawca
DOI
URL
Rok publikacji
2016
Numer zeszytu
Strony od-do
126-132
Numer tomu
135
Identyfikator DOI
Liczba arkuszy
Słowa kluczowe
en
Recombinant insulin
Pharmaceutical form
PFGSE NMR
Nanospray ESI–MS
Streszczenia
Język
en
Treść
A monomer structure of a novel human insulin analog A22S-B3K-B31R (SK3R) has been characterized by NMR in water/acetonitrile solution and compared with the structure of human insulin (HIS) established in the same medium. The composition of the oligomer ensemble for neat insulins in water was qualitatively assessed by monitoring, derived from NMR experiment, translational diffusion coefficient Di x 10−10 m2 s−1, whose value is a population averaged of individual coefficients for species in oligomeric ensemble. Nanospray ESI/MS experiment was used to establish the masses of oligomers in pharmaceutical formulation of the SK3R insulin. The pharmacodynamic data were established and compared to insulin glargine characterized by the same profile of action in diabetics. The oligomerization process of insulin during development of pharmaceutical formulation with routinely used excipients has been studied using translation diffusion coefficient Di x 10−10 m2 s−1 established in water solution. These properties were compared with those of human insulin (HIS) which is a standard reference for novel recombinant insulins.
Cechy publikacji
oryginalny artykuł naukowy
Inne
System-identifier
769520a335110fae051779dfb83b092f
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